Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

FDA device recall Z-1680-2026 · posted 2026-03-27 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Action taken

On March 3, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue and follow the instructions below. 2. Perform the daily check before starting the first procedure, as described in the device labelling 3. Should you experience a foot switch activation issue, please report it to your local Philips representative. 4. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 5. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 6. Complete and return the response form included in this Urgent Medical Device Correction letter to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken.

Root cause

Device Design

Status

Open, Classified

Product code

OWB

Quantity affected

920 units (168 US, 752 OUS)

Distribution

Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina

Date initiated

2026-03-03

Date posted

2026-03-27

Location

Best, Netherlands